Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications
|ClinicalTrials.gov Identifier: NCT00433992|
Recruitment Status : Completed
First Posted : February 12, 2007
Results First Posted : July 31, 2017
Last Update Posted : September 5, 2017
|Condition or disease|
The main objective of this study is to observe the effects of anti-HIV medication lacking thymidine on mitochondrial metabolism and adipocyte apoptosis (fat cell death). Changes in mitochondrial metabolism and increases in adipocyte apoptosis are associated with lipoatrophy. Lipoatrophy is a common condition characterized by loss of subcutaneous fat and can be caused by many anti-HIV medications. This study will examine the metabolic consequences of the use of thymidine analogue-sparing treatment regimens.
This study will evaluate HIV infected patients who are enrolled in ACTG A5202, starting their first nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen. This regimen will include either tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or abacavir/lamivudine (ABC/3TC), which are thymidine-sparing regimens. The changes in mitochondrial activity and fat cell death will be compared between participants taking thymidine-sparing regimens (TDF/FTC or ABC/3TC) and thymidine-containing regimens.
This study will last for 96 weeks, with two study visits occurring at entry and another visit at Week 96. During each visit, a dual energy x-ray absorptiometry (DEXA) scan and blood collection will occur, and a fat biopsy will be performed in the lower abdomen under local anesthetic.
|Study Type :||Observational|
|Actual Enrollment :||56 participants|
|Official Title:||Effects of Thymidine Sparing Regimens on Mitochondrial Metabolism and Adipocyte Apoptosis|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||December 2009|
HIV-infected subjects were given Abacavir-Lamuvidine
HIV-infected patients were given tenofovir DF-emtricitabine
- Change in Mitochondrial Activity [ Time Frame: Entry, Week 96 ]mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.
- Change in Fat Apoptosis [ Time Frame: Entry, Week 48 ]Changes in limb fat from 0 to 48 weeks measured with whole-body dual-energy x-ray absorptiometry
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433992
|United States, Ohio|
|Case School of Medicine|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Grace McComsey, MD||Case School of Medicine|